BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK

    K Number: K932057 · Decision Aug 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    264
    Applicant Total
    5
    Review Days
    464

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    Basic Information

    Device Name
    BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK
    K Number
    K932057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Board of Directors, Albert Browne , Ltd.
    Date Received
    April 28, 1993
    Decision Date
    August 5, 1994
    Product Code
    JOJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOJ Indicator, Physical/Chemical Sterilization Process

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    Other Clearances by Board of Directors, Albert Browne , Ltd.

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    K971971 BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK
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    K922481 BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE
    K902958 TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE